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FDA Warns Against Alternative Autism Therapy

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The Food and Drug Administration is warning consumers that a therapy often marketed for treating autism, cerebral palsy and other conditions is unproven and may “endanger their health.”

Federal regulators said Thursday that contrary to many claims on the Internet, hyperbaric oxygen therapy is not clinically proven to cure or effectively treat the developmental disorders and many other conditions.

“Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by the FDA, which may cause them to delay or forgo proven medical therapies,” said Nayan Patel, a biomedical engineer at the FDA’s anesthesiology devices branch. “In doing so, they may experience a lack of improvement and/or worsening of their existing conditions.”

Despite limited research, hyperbaric oxygen therapy has become a popular alternative treatment for autism and cerebral palsy. For the therapy, individuals spend time in a pressurized chamber allowing the lungs to take in as much as three times the normal amount of oxygen.

Hyperbaric oxygen therapy is FDA approved for thirteen different uses including the treatment of thermal burns, carbon monoxide poisoning and decompression sickness that’s sometimes experienced by divers.

But, in issuing the consumer alert this week, regulators listed more than a dozen conditions ranging from autism and cerebral palsy to cancer, AIDS, Alzheimer’s disease and hepatitis for which the therapy is marketed even though the FDA has not approved such uses.

Patel indicated that the agency has received 27 complaints in the last three years from consumers or health care professionals about treatment centers promoting hyperbaric oxygen therapy for uses that are not approved.

Possible risks of hyperbaric oxygen therapy include sinus pain, ear pressure or joint pain as well as more serious problems like paralysis or air embolism, which can obstruct circulation in the body, the FDA said.

This is not the first time a treatment advertised as helping those with autism has been specifically called out by the FDA. In 2010, the agency told eight businesses to stop marketing chelation products to those with autism and other conditions citing serious side effects including death.

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Comments (24 Responses)

  1. Ken Stika says:

    There sure are of lot of “possible”, “may”, and outright skepticisms in this warning. “Despite limited research!” Hello, wouldn’t it be conducive to medical science to actually DO some research so as to prove or disprove the efficacy of said treatment so as to actually remove the “may” and “possible” from medical doctrine. I “MAY” get into a car accident while driving with all of the idiots texting, but it doesn’t mean that I should not drive. It is “POSSIBLE” to get a sinus headache from too much dairy products but I don’t see any warnings about the possibility of cancer, osteoporosis, or death from using animal products but OXYGEN “may” give joint pain or even paralysis. Wow. while I appreciate the fact that such an entity exists so as to keep snake oil salesman “honest”, I wish that the FDA would put their money where their mouth is and stop playing games with peoples live. Could we see some research that would is approved so that there is a DEFINITIVE answer to this controversial matter which is only controversial because the FDA hasn’t pursued the acquisition of DATA so that we no longer have to “endanger the health” of children whose health has already been put at risk through other FDA approved “healthful” and “helpful” medications.

  2. LL says:

    Arguments about Autism that invoke “the children” are suspect. There are more Autistic adults than Autistic children. Ignoring that erases an important part of the lives of Autistic people. Frequently people who want to eliminate Autistic people (often through prenatal testing) focus their argument on the children when it is not the child who they are advocating for, but the parent(s). It is particularly ableist to infantilize people who are developmentally different.

  3. Mickie says:

    Hey look modern medicine has nothing of any real value for autism until you do shut up and let people do what they need to. its survival we all care about our kids and it is sometimes so bad you grasp for any kind of help so either put up or shut up.

  4. Linda says:

    Done incorrectly, just about any medical treatement can cause problems, just like with Hyperbaric Oxygen therapy. The FDA has not been on the side of patients in many instances so I”m not going to jump on the bandwagon here. Kids with autism and cerebral palsy have brain damage. Hyperbaric oxygen therapy is for hte treatement of brain damage and therefore has been helpful in treating many childhood disorders. Use of HBOT by untrained and less than knowledgable practitioners should not be encouraged, but those who know what they are doing can be very helpful.

  5. Kerry says:

    @Linda: Actually, no, those who are autistic don’t have brain damage. They have a different neurology. A different way of seeing and processing the world doesn’t equal a damaged way. Those two things are not the same, so please do your research and choose your words more carefully.

  6. Al says:

    THE FDA what a joke, they make recommendations but offer no solutions.
    They started this epidemic and what have they done to remedy it. Zero, nada
    zilch.

  7. A dad says:

    Hyperbaric oxygen saved my child with autism. Considering the FDA does very little to help our kids I would be very angry if they took something away THAT ACTUALLY WORKS!

  8. Lisa Ackerman @ TACA says:

    In the years of knowing about HBOT, I have yet to hear a family share that their child was injured. At TACA, we serve or 35,000 families.

    Many families living with autism report positives from this treatment prescribed and monitored by a physician.

    It is a shame to see the FDA go after something that works. Can they offer an alternative that provides positives for families living with autism?

  9. Diana says:

    I find it interesting that this “warning” is being made about HBOT, when almost every commercial on TV advertising FDA approved medicines comes with a laundry list of possible side effects. It always makes me wonder how they got approved. Why is it ok for these medications to have side effects but HBOT can’t have any side effects. I don’t think there are any medications/therapies that are 100% safe for everyone. Everybody is different so medicines/therapies will effect them differently. Also, its not like the FDA is perfect….how many medications approved by the FDA, end up being recalled?

  10. mom of two says ASD girls says:

    I was told try everything that won’t harm them..you only have 5 years to heal the brain!!!!(no pressure)!!! This was eight years ago!!! All I know is after HBOT my children began talking more, listening more, and and came out calm without anxiety. I would have stopped if there was the slightest negative effects. My kids are doing so well today….There is science and warnings, and then there are parents who want their children to have a full life and can’t wait 10 years for small risks… I feel each has the right to make their own decision…And it wasn’t an easy decision. I was petrified of every new treatment but brave enough to try,pay attention,document improvements or negative aspects and continue or stop…it WAS simply working so I continued.Of course I’m ONLY a parent! If your kids heavy metal toxin screens come back off the charts what would you do? Could you be OK with your Daughter filled with Mercury? Seriously!!!!

  11. Holly Rileu says:

    Mild HBOT has helped my son recover from autism. He no longer qualifies for the diagnosis. It was a period while doing a combination of HBOT with a no starch diet and high dose methylcobalamin (daily subcutaneous injections of vitamin B12) when we saw the fasted gains in language, communication and overall ability to learn. None of these very safe treatments is FDA approved, but the vaccines that caused his initial injuries are FDA approved (and known to be “unavoidably unsafe” Accor ding to the US Supreme Court). The FDA stamp of approval is fraught with egregious conflicts of interest that often have more to do with money than health. HBOT is a tremendous tool for healing and it’s use should be expanded not decreased. There is plenty of clinical evidence that HBOT is safe and effective, but the FDA’s friends at Big Pharma won’t make money on that. Google and research for yourself at pubmed.

  12. Jennifer says:

    The FDA isn’t saying not to do hyperbaric therapy. It’s approved for a lot of things. But there are places advertising it as a “CURE! your autism/Alzheimer’s/cancer NOW!” and people are getting scammed and giving these places their life savings.

  13. Cathy says:

    I am so glad you posted this, a friend of ours recommended this for our son, but we were unsure of it as we had heard very little until now. our son is Autistic and will be 23 this coming October. Bless your hearts and please continue to help us stay informed

  14. Aspie says:

    Autism is not a disease, it’s not something that needs treatment. It’s a simple difference, like being gay rather than straight. The majority are NT, but that doesn’t make autism something to avoid, treat, or seek “help” for.
    I should know, I have autism.

  15. SK says:

    Actually, Kerry, some with autism have experienced brain injury, and others are born with different neurology.

  16. David Snow says:

    My son has grown up for the past 11 years with hundreds and hundreds of hyperbaric oxygen therapy treatments in the USA and Canada and we even wore out an at home mild chamber as an adjunctive therapy for his cerebral palsy. His Neurologist has a set of chambers for the treatment of cerebral palsy. This warning is unwarranted. The FDA is a tool of the drug companies. Treating spasticity with oxygen versus drugs has worked for my son.

  17. Michael Maloney says:

    Since the first herbs and plants were found useful in helping humans become or remain more healthy, there have always been the snake oil salesmen who prey on the desperation of the afflicted. The practice continues into the modern with and without government oversight. There have been many effective cures, such as the current polio vaccine. There have also been catastrophic errors, like Thalidomyde.
    The surest way to create, test, produce and distribute any health product or procedure is through a regimen of rigorous scientific testing BEFORE going to market. Anyone involved with non-compliance to such a policy should be subject to sufficiently punishing consequences that will inhibit their desire and/or ability to re-offend.
    As a publisher, I rely on the more than 50 years of research that supports each of the three methods integrated into our Teach Your Children Well materials.
    As a Rotarian, I am reliant on the published research on the polio vaccine that we are dispensing to virtually every child on the planet. After 15 years, Rotary and its partners, governments and philanthropists have eradicated polio in all but 2 countries in the world; Afghanistan and Pakistan.
    Success for human in health, education or any other area is contingent upon scientifically proven products and a constant vigilance against those who would shortcut the system for personal or corpoate gain.

  18. Kate says:

    My son started hyperbaric therapy and I didn’t tell his private OT, private speech therapist or early childhood teacher in addition to the school PT and OT. They all recorded a massive jump in skills. He started talking in sentences, responding to his name, began using verbs (met semester goal in one week), improved motor skills, showed interest in other children, etc. all in a very short period of time and the gains were immediate. it was a huge game-changer for us and we continue to do this therapy on a regular basis. It is very safe. I find it very helpful for healing sports injuries. There are several peer-reviewed studies that support its use with the ASD population.

  19. Lynne says:

    There are many therapies that the FDA does not approve of and hasn’t in the past. In the treatment of AIDS, medications were kept from those suffering with the disease that were being used in Europe and were helping people. Many people died while the FDA made decisions about whether or not they approved a medication that others were using and living. There are two sides to every story. The FDA doesn’t always act in the best interest of those suffering. They also approve many medications that are later recalled because of the damage they have done. It is not an infallible institution.

  20. Whitney says:

    I am not sure if there is a study on this treatment to show actual improvement for Autism. Autism the brains are structured differently so is not brain damage or even an actual disease it might help with sensory inputs which skewed. So it seems to create placebo effect where things appear better but not. There is no cure for autism nor there is one for being Nuero-typical. The people who believe in this treatment are being fleece and so is the insurance company. There is no quick fixes. Please do your research.

  21. vmgillen says:

    Until a solid etiology is worked out, ANYTHING might cure autism, for heaven’s sake.

    People with ASD can have TBIs, or chicken pox, or…

    I do so wish the ADA hadn’t included everyone under the ASD rubric. It makes me crazy to read “don’t cure us” as a universal statement for the entire population. Without one-to-one (or often two-to-one) coverage my son, a non-verbal adult, will bite himself ’til he bleeds, run into traffic, start fires, and cause serious harm and damage. An adult should be able to self-direct: he can not. That needs to change. Call it a cure if you want.

    At the same time, because the Dx encompasses such a wide spectrum, people who use the latest cure-all on children with higher functioning capabilities look smugly urge me to pursue (fill in the blank) because it worked wonders for them.

    I say, caveat emptor anything that claims to cure many different things – i.e. cancer, hair loss, and autism.

  22. yankeegirl says:

    “If you can argue for a cure, then you don’t need one” – Natalie Palumbo, Autism sibling

    The above statement is so true. Some Aspies and HFA insist THEY don’t want a cure or autism. But what about the lower functioning children who cannot advocate for themselves many of whom have a host of medical issues such as GI problems, mitochondrial dysfunction and brain inflammation. Would you deny them an opportunity for treatment that may help them because YOU don’t need/want a cure??? To me that is narrow minded thinking and selfish. If you don’t want a cure for autism fine but do not deny access treatments that may benefit others.

  23. Lyelle Palmer, Ph.D. says:

    Why such negative headlines and text. If this therapy is so dangerous then why is it approved for all of these other problems. Call it what it is: It is in the “experimental” rather than “approved” phase.

  24. Beverly Johnson says:

    I am currently working on a piece warning about the dangers of the FDA

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